MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER

Patient Problem Insufficient Information (4580)

Event Date 02/06/2024

Event Type  Death  

Event Description

Patient's spouse reported patient passed away on (b)(6) 2024.When investigating the patient's pump and cassette she was utilizing the day of passing, he discovered that the pump showed 98 ml had been given.This did not align with what was seen in the bladder of the cassette (he stated approximately half full).He also advised that there were air bubbles present in the bladder as well.Spouse advised he's adamant about ensuring there are no air bubbles present when preparing the cassettes.The patient's death was relatively unexpected and took place at home.Spouse gave no indication that there were alerts during the two days leading up to the patient's death.Last cassette was placed on (b)(6) 2024.Pump serial number: (b)(6) /no due date.Spouse has pump/cassette on hand for return.Pharmacy notified md office.Unknown if cassette/pump or both contributed to event.No lot number/expiration date for cassette provided.No further information.Date of last dose unknown.Cause of death not provided.Iv remodulin patient.Pump return tracking information is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is not applicable.No additional information available at this time.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? yes.Is the actual device available for investigation? yes.Did we replace the device? not applicable.Did the patient have a backup device they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? not applicable.Is the infusion life-sustaining? yes.Reported to (b)(6) by: patient/caregiver.Reference report: mw5151553.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 18702998
• MDR Text Key: 335461699
• Report Number: MW5151554
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPSUMIT.; PUMP CADD LEGACY.; REMODULIN MDV.
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Sex: Female